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On October 6, 2026, the U.S. Food and Drug Administration issued a final order removing the 510(k) premarket notification requirement for certain clinical toxicology test systems intended for federal drug testing programs, effective immediately.
In other words, oral fluid testing has moved one step closer to implementation, but employers still need the required HHS-certified laboratories before using this method.
The removed requirement was a primary obstacle for laboratories seeking certification to perform oral fluid testing. The FDA’s 510(k) process previously required a device manufacturer to demonstrate that its product was substantially equivalent to a legally marketed device. However, systems intended for federal drug testing programs were excluded from eligibility.
The FDA’s final order removed that exclusion (within certain specific limitations), and manufacturers of eligible systems no longer need to complete the 510(k) process for use in federal programs.
The FDA exemption changes one requirement. Laboratory certification and collection-device requirements still apply.
FDA exemption changes and remaining requirements for DOT oral fluid testing.
| Area | What Changed or Still Applies | What Employers Should Know |
|---|---|---|
| FDA Exemption | The October 6, 2026 order exempts certain clinical toxicology test systems intended for federal drug testing programs from 510(k) premarket notification, subject to limitations. | The exemption does not independently authorize employers to begin DOT oral fluid testing. |
| Laboratory Certification | DOT requires at least two HHS-certified oral fluid laboratories to support primary and split-specimen testing. | As reviewed October 15, 2026, DOT’s published list reports no certified oral fluid laboratories. Check the list before implementing testing. |
| Laboratory-Specific Collection Devices | Employers must use collection devices approved by HHS and the National Laboratory Certification Program for their selected laboratory. | Confirm the laboratory and its listed collection device before arranging collections. |
Sources: FDA final order and DOT laboratory and collection-device requirements.
Oral fluid testing for DOT-regulated employers, however, cannot begin in earnest until the required laboratories are certified by the Department of Health and Human Services (HHS).
DHHS must certify at least two oral fluid laboratories: one for primary testing and another for split-specimen testing.
As of October 15, 2026, DOT’s published laboratory list still reports no HHS-certified oral fluid laboratories. Additionally, employers must still use collection devices approved for use with their selected laboratory. As of right now, the FDA has not specified a launch date for these certifications.
Oral fluid testing would give employers another specimen collection process for their regulated drug testing programs, while reducing opportunities for cheating and facilitating a less intrusive collection process.
Once implementation requirements are met, employers can choose which permitted method they want to use, consistent with applicable rules.
If you're a DOT-regulated employer, you can start thinking about where you would use oral fluid testing and what your providers would need to support it. Discuss these questions with your testing provider:
No. DOT rules do not authorize point-of-collection oral fluid or instant drug tests. DOT drug testing requires specimens screened and confirmed at HHS-certified laboratories.
DISA Global Solutions helps employers manage transportation compliance and workplace testing programs through policy support, training, and program administration. As regulations evolve, DISA helps employers stay informed of changing requirements and maintain compliant workplace drug testing programs.
Contact DISA to learn more about regulatory developments and how we can support your workplace drug testing and compliance needs.
DISA Global Solutions aims to provide accurate and informative content for educational purposes only and does not constitute legal advice. The reader retains full responsibility for the use of the information contained herein. Always consult with a professional or legal expert.
October 20, 2026
3
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